Next weekNext week on March 27, 2024 is the next step for CZO towards closing the merger.
AEZS's financials are also due by the end of this month. Its clinical trial for the growth hormone deficiency test was to be fully enrolled by the end of 2023. Are the clinical trial results now imminent along with a new North American deal for the test and filing for regulatory approval? This may be the biggest near-term catalyst. Current growth hormone deficiency testing requires two growth hormone deficiency tests. AEZS's clinical trial is set up to support only requiring one test. Being able to ditch the requirement of a second test could be a game-changer for patients. This trial is also set up for the key childhood market. Being able to launch the product across all age groups could be a major advance in terms of marketing the test. For a number of global markets(eg. China) the childhood market is also the major market due to a lack of awareness in the adult population. We will see how much AEZS can secure in terms of upfront and near-term potential cash from a new North American deal in the context of the previous deal with Strongbridge. Adjusted for inflation Strongbridge's upfront payment alone was worth ~C$40 million and they also had to pay a US$5 million milestone for pediatric approval as well as cover pediatric trial costs.
In AEZS's October presentation it expected NMOSD results with the largest teaching hospital of Harvard in the "very near future". It will be about 5 months next week. Did they send it off to be published in a scientific journal? Harvard has worked on past NMOSD programs and are using their specific tests to validate AEZS's program. They may be able to provide an authoritative endorsement of AEZS's program as it potentially nears clinical trials. Has AEZS closed the gap to clinical trials for its pipeline programs and what will the trials look like?
Last month CZO also said about PGX, "Pending receipt of remaining automation components, commissioning expected to be completed by end of Q1 2024." This 5X PGX scale-up is expected to provide material for potential partners and puts CZO one step away from the potential 10X scale-up expected to be commissioned in Q3. The 10X scale-up allows small-scale commercial production and brings PGX to the decision point for mass industrialization. At the last AGM CZO noted that it was in discussions with serious potential partners who understand the unique selling point of bioavailability for CoQ10.